Patient leaflet - Ayvakyt 300 mg film-coated tablets
1. What AYVAKYT is and what it is used for
T
serious fungal infections
- Conivaptan – used to tre
The following medicines can
- Rifampicin – used to trea infections
- Carbamazepine, phenytoi to treat epilepsy
- St. John’s wort (Hypericu depression
What AYVAKYT is
AYVAKYT is a medicine containing the active subst
What AYVAKYT is used for
AYVAKYT is used in adults to treat a type of digesti gastrointestinal stromal tumour (GIST), when it can (unresectable) or has spread to other parts of the b has a specific mutation (D842V) in the gene for pla receptor alpha (PDGFRA) protein kinase.
How AYVAKYT works
ance avapritinib.
ve tract cancer called not be treated with surgery ody (metastatic) and that telet-derived growth factor
- Bosentan – used to treat
- Efavirenz and etravirine –
- Modafinil – used to treat
- Dabrafenib – used to trea
- Nafcillin – used to treat c
- Dexamethasone – used t
Avapritinib may increase the
- Alfentanil, fentanyl - used procedures
- Sirolimus, tacrolimus, cic
AYVAKYT stops the activity of a group of proteins in Cells that make up the cancer usually have change involved in making specific kinases associated wit these cells.
If you have any questions about how AYVAKYT wor been prescribed for you, please ask your doctor.
2. What you need to know before you take AYV
the body called kinases. s (mutations) in the genes h the growth and spread of ks or why this medicine has
AKYT
rejection
- Dihydroergotamine, ergot headaches
- Pimozide - used to treat
- Amiodarone - used to tre
- Citalopram, escitalopram
- Ondansetron - used to tr
- Ethinyl estradiol - hormo
Ask your doctor or pharmaci
Do not take AYVAKYT:
- if you are allergic to avapritinib or any of the ot medicine (listed in section 6).
Warnings and precautions
Talk to your doctor or pharmacist before taking AYV
- if you have suffered a vascular aneurysm (b a blood vessel wall) or bleeding in your brain
if you are taking a medicine that thins the blo such as warfarin, phenprocoumon, rivaroxaba
her ingredients of this
AKYT:
ulging and weakening of in the last year.
od to prevent blood clots n, dabigatran, apixaban,
AYVAKYT with food and dri
You should not drink grapefr AYVAKYT.
Pregnancy, breast-feeding
If you are pregnant or breast planning to have a baby, ask this medicine.
Pregnancy edoxaban or another medicine that thins the b
Take special care with this medicine:
- You may develop symptoms such as severe he severe sleepiness, or severe weakness on o (signs of bleeding in your brain). If these occ immediately and temporarily stop treatment.
Treatment with this medicine may lead to a hig
Avapritinib can cause bleeding in the digestive rectum or intestine. Avapritinib can also cause as bleeding of the tumour. Tell your doctor if yo
lood to prevent blood clots.
adache, vision problems, ne side of your body ur, contact your doctor her risk of bleeding. system such as stomach, bleeding in the liver, as well u had or have any bleeding
This medicine is not recomm necessary. Avoid becoming p it may harm your unborn bab risks of taking AYVAKYT duri
Your doctor may check if you medicine.
Women who are able to bec during treatment and for at l with females partners who a problems. Before you start taking avapritinib yo do blood tests. Get medical help immediately, if symptoms: passing blood in the stools or passi pain, coughing/vomiting up blood.
You may also develop memory loss, changes i
(signs of a cognitive effect). Avapritinib can s think and how you remember information. Cont you experience these symptoms or in case a fa someone who knows you notices that you are g
During treatment with this medicine, tell your d put on weight very quickly, develop swelling
ur doctor may decide to you get the following ng black stools, stomach n memory, or be confused ometimes change how you act your doctor in case mily member, caregiver or etting forgetful or confused. octor straight away if you of your face or limbs,
contraception during treatm treatment. Talk to your docto be right for you.
Breast-feeding
Tell your doctor if you are br known if AYVAKYT passes int treatment with this medicine Talk to your doctor about the have difficulty breathing or become short of cause your body to retain water (severe fluid re
- Avapritinib may cause abnormality of your he may conduct tests to evaluate these problems with avapritinib. Tell your doctor if you feel dizz heartbeats while taking this medicine.
- You may get severe stomach and bowel prob and vomiting). Get medical help immediately i symptoms.
You may become more sensitive to the sun w
breath. This medicine may tention).
art rhythm. Your doctor during your treatment y, faint, or have abnormal lems (diarrhoea, nausea f you experience these hile taking this medicine.
Fertility
AYVAKYT may cause fertility doctor if this is a concern for
Driving and using machine
AYVAKYT may cause sympto (see section 4). Therefore, AY machines. Take special care experience these side effect
AYVAKYT contains sodium
It is important to cover sun-exposed areas of sk high sun protection factor (SPF).
While you are taking avapritinib, your doctor will as tests. You will also be weighed regularly.
For more information see section 4.
in and use sunscreen with k you to have regular blood
This medicine contains less say essentially “sodium-free
3. How to take AYVAKYT
Always take this medicine e Check with your doctor or ph
ed in children and adolescents under age 18. Do dren or adolescents under the age of 18 years.
KYT st if you are taking, have recently taken or might VAKYT may affect the way other medicines work, may affect how this medicine works.
Which stre
AYVAKYT is 50 mg, 100 strength an
Treatment
The recom
If you have cist before taking AYVAKYT if you are taking ines:
increase the effects of avapritinib and may t hepatitis C avir, nelfinavir, ritonavir, saquinavir – used to treat ycin, telithromycin – used to treat bacterial e, posaconazole, voriconazole – used to treat
AYVAKYT.
If you get s permanent unless your
Swallow th stomach. D AYVAKYT.
If you vomi at low blood sodium levels (hyponatraemia)
reduce the effects of avapritinib:
t tuberculosis (TB) and some other bacterial n, fosphenytoin, primidone, phenobarbital – used m perforatum) – an herbal medicine used for
your next d
If you take
If you have away. You
If you forg
If you miss next sched time.
high blood pressure used to treat HIV infections/AIDS sleep disorders t certain cancers ertain bacterial infections
o reduce inflammation side effects of the following medicines: to control pain during operations and medical losporin - used to prevent organ transplant
Do not take
4. Possibl
Like all me everybody
Most serio Some side get any of amine - used to treat migraines and cluster psychosis and Tourette disorder at heart rhythm problems
used to treat depression eat nausea or vomiting nal oral contraceptive st for advice before taking any medicine.
- severe one sid
- memor
Other side Very comm
- decreas
- memor
- dizzines
- altered nk uit juice or eat grapefruit while on treatment with and fertility
-feeding, think you may be pregnant or are your doctor or pharmacist for advice before taking
- increas
- abdomi
- nausea,
- diarrho
- dryness
- heartbu
- change
- rash
- swelling
- tirednes ended for use during pregnancy unless clearly regnant while being treated with this medicine as y. Your doctor will discuss with you the potential ng pregnancy.
are pregnant before you start treatment with this ome pregnant should use effective contraception east 6 weeks after completion of treatment. Males re able to become pregnant should use effective
- blood te cells
- blood te bilirubin
Common (
- red, or
- dehydra
- low alb
- depress
- anxiety ent and for at least 2 weeks after completion of r about effective contraception methods that may east-feeding or planning to breast-feed. It is not
o breast milk. You should not breast-feed during and for at least 2 weeks following the last dose. best way to feed your baby during this time.
- trouble
- bleedin
- decreas arms an
- feeling
- speech
- movem
- headac
- tremor
- bleedin
- increas problems in males and females. Talk to your you.
s ms that affect your ability to concentrate and react VAKYT may influence the ability to drive and use when driving a car or operating machines if you s.
- increas
- shortne
- stuffy n
- cough i
- gastroin
- increas
- constip
- difficult
- painful
- increas than 1 mmol sodium (23 mg) per tablet, that is to ”.
xactly as your doctor or pharmacist has told you. armacist if you are not sure.
- red or it
- skin dis
- hair los
- pain
- muscle
- blood in
fever or
ngth of AYVAKYT to use available in different tablet strengths. The strengths are 25 mg, 200 mg and 300 mg. Your doctor will advise you about d number of tablets you should take:
of GIST mended dose is 300 mg by mouth once daily.
liver problems, your doctor may start you on a lower dose of
mg, the
- changes in the electric activity of the he
- weight gain or loss
- blood tests showing low blood platelets, bruising or bleeding
- blood tests showing altered amounts of
- blood tests showing decreased kidney fu
- blood tests showing increased break do
Uncommon (may affect up to 1 in 100 peop ide effects, your doctor may change your dose, temporarily s ly stop treatment. Do not change your dose or stop taking AY doctor tells you to.
e AYVAKYT tablet(s) whole with a glass of water, on an empty
o not eat for at least 2 hours before and at least 1 hour after t after taking a dose of AYVAKYT, do not take an extra dose. T
top, or
VAKYT taking ake
- bleeding in the tumour
- fluid around the heart
- bleeding in the liver
Reporting of side effects
If you get any side effects, talk to your docto any possible side effects not listed in this le effects directly via the Yellow Card Scheme or search for MHRA Yellow Card in the Goog reporting side effects you can help provide this medicine.
ose at your scheduled time.
more AYVAKYT than you should accidentally taken too many tablets, talk to your doctor strai may require medical attention.
et to take AYVAKYT a dose of AYVAKYT, take it as soon as you remember unless uled dose is due within 8 hours. Take the next dose at your r
ght your egular
5. How to store AYVAKYT
Keep this medicine out of the sight and reac
Do not use this medicine after the expiry da label and outer carton after ”EXP”. The expi month.
two doses within 8 hours to make up for a forgotten dose.
e side effects dicines, this medicine can cause side effects, although not gets them.
us side effects effects may be serious. Tell your doctor straight away if the following (see also section 2.):
you
This medicine does not require any special
Do not use this medicine if you notice that t signs of tampering.
Do not throw away any medicines via waste your pharmacist how to throw away medici measures will help protect the environment.
6. Contents of the pack and other inform
headache, vision problems, severe sleepiness, severe weakn e of your body (signs of bleeding in your brain) y loss, changes in memory, or confusion (signs of a cognitive effects may include:
on (may affect more than 1 in 10 people):
ed appetite y loss, changes in memory, or confusion (cognitive effects) s taste
ess on effect)
What AYVAKYT contains
The active substance is avapritinib. Each
300 mg avapritinib.
The other ingredients are:
- The tablet core contains: microcryst croscarmellose sodium and magnes “AYVAKYT contains sodium”).
- The tablet coating contains: talc, ma and titanium dioxide (E171).
ed tear production nal (belly) pain retching and vomiting ea affecting eyes, lips, mouth and skin rn in hair colour
(e.g. feet, ankle, face, eye, joint) s sts showing decrease in red blood cells (anaemia) and white sts showing increased stress on the liver and high levels of , a substance produced by the liver may affect up to 1 in 10 people):
painful eye, blurry vision tion umin in the blood ion
blood contains one bottle.
Keep the desiccant canister in the bottle.
Marketing Authorisation Holder and Man
Blueprint Medicines (Netherlands) B.V. Gustav Mahlerplein 2
1082 MA Amsterdam
Netherlands
For any information about this medicine, ple falling asleep (insomnia)
g in your brain ed sensation, numbness, tingling, or increased sensitivity to d legs weak or unusually sleepy disorder or hoarse voice ent disorder he g in the eye ed sensitivity to light
pain in
Authorisation Holder:
Blueprint Medicines (Netherlands) B.V., NL Tel: +31 85 064 4001 e-mail: MedinfoEurope@blueprintmedicines
This leaflet was last revised in March 20
This medicine has been given ‘conditional a This means that there is more evidence to c ed blood pressure ss of breath ose ncluding cough that produces mucus testinal bleed ed fluid in the abdomen ation, flatulence (gas)
y swallowing mouth, lips or tongue, thrush e in saliva production chy skin colouration s spasms urine feeling of general discomfort
art often associated with easy blood minerals nction wn of muscle le):
r or pharmacist. This includes aflet. You can also report side at https://yellowcard.mhra.gov.uk/ le Play or Apple App Store. By more information on the safety of h of children.
te which is stated on the bottle ry date refers to the last day of that storage conditions.
he bottle is damaged or shows water or household waste. Ask nes you no longer use. These ation film-coated tablet contains alline cellulose, copovidone, ium stearate (see section 2 crogol 3350, poly(vinyl alcohol),
- The printing ink contains: Shellac gl ethanol, Brilliant blue FCF (E133), tit oxide (E172) and propylene glycol.
What AYVAKYT looks like and contents o
AYVAKYT 300 mg film-coated tablets are ov and 9 mm in width, printed with blue ink “B other.
AYVAKYT is supplied in a bottle containing 3
aze 45% (20% esterified) in anium dioxide (E171), black iron f the pack al, white tablets of 18 mm in length LU” on one side and “300” on the
0 film-coated tablets. Each carton ufacturer ase contact the Marketing
.com
26 pproval’.
ome about this medicine.
The Medicines and Healthcare products Reg new information on this medicine at least e updated as necessary.
ulatory Agency (MHRA) will review very year and this leaflet will be
60004702-XX